FDA 510(k) Application Details - K024125

Device Classification Name Appliance, Fixation, Spinal Intervertebral Body

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510(K) Number K024125
Device Name Appliance, Fixation, Spinal Intervertebral Body
Applicant MICOMED ORTHO GMBH
13195 SEAGROVE ST.
SAN DIEGO, CA 92130 US
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Contact CORRINE M BONFIGLIO
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Regulation Number 888.3060

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Classification Product Code KWQ
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Date Received 12/16/2002
Decision Date 09/22/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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